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FDA 510(k) clearances and recalls: Clinical Chemistry devices

15 FDA 510(k) clearances and recalls: Clinical Chemistry devices are listed from U.S. FDA openFDA, dated 2026-09-11 to 2026-10-23; the most frequent is Beta Bionics, Inc. with 2. Data last updated 2026-11-03; each record links to its official source and a full report.

Data as of · Compiled by Zalwin from U.S. FDA openFDA

Includes: Record, Specialty, Date, Review days, Recall class, official source URL and score · Card, Apple Pay, Google Pay or Link via Stripe

Free sample: 3 records (CSV)

15 records from U.S. FDA openFDA, dated 2026-09-11 to 2026-10-23. Most frequent: Beta Bionics, Inc. (2). Each record links to a full report and the official source.

Last updated 2026-11-03. Source: U.S. FDA openFDA.

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Records
15
Most frequent
  1. Beta Bionics, Inc. (2)
  2. Beckman Coulter, Inc. (2)
  3. Becton, Dickinson and Company (1)
  4. EPS Bio Technology Corp. (1)
  5. Sol-Millennium Medical, Inc. (1)

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What are the top FDA 510(k) clearances and recalls: Clinical Chemistry devices right now?

RecordSpecialtyTypeDate
BD Vacutainer® Serum Blood Collection Tubes; BD Vacutainer® Rapid Serum Tubes (RST) (K252344): 510(k) cleared for Becton, Dickinson and CompanyClinical Chemistry510(k)2026-10-16
EASYMAX Voice Blood Glucose Monitoring System (K261293): 510(k) cleared for EPS Bio Technology Corp.Clinical Chemistry510(k)2026-10-23
Sol-Guard™ Safety Pull Button Collection Set; Sol-Guard™ XtraThin Safety Pull-Button Blood Collection Set (K260857): 510(k) cleared for Sol-Millennium Medical, Inc.Clinical Chemistry510(k)2026-10-21
Mint ACE Pump (K260001): 510(k) cleared for Beta Bionics, Inc.Clinical Chemistry510(k)2026-09-11
CVS Advanced PLUS Blood Glucose Monitoring System (K260689): 510(k) cleared for I-Sens, Inc.Clinical Chemistry510(k)2026-10-02
VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System;VivaChek Blood Glucose and ß-Ketone Dual Monitoring System. (K260687): 510(k) cleared for Vivachek Biotech (Hangzhou) Co., Ltd.Clinical Chemistry510(k)2026-10-09
H100Plus Hemoglobin Testing System (K260468): 510(k) cleared for Shenzhen Lifotronic Technology Co., Ltd.Clinical Chemistry510(k)2026-10-02
Mint ACE Pump (K263422): 510(k) cleared for Beta Bionics, Inc.Clinical Chemistry510(k)2026-10-21
Access BNP II (K262597): 510(k) cleared for Beckman Coulter, Inc.Clinical Chemistry510(k)2026-10-20
twiist Loop Algorithm (K262576): 510(k) cleared for Deka Research and Development Corp.Clinical Chemistry510(k)2026-10-15
Profoject™ Safety Sliding Blood Collection Set (K262215): 510(k) cleared for CMT Health PTE., Ltd.Clinical Chemistry510(k)2026-09-25
Instant-View® hCG Combo II Cassette Test (K262299): 510(k) cleared for Alfa Scientific Designs, Inc.Clinical Chemistry510(k)2026-09-22
Access NT-proBNP (K262109): 510(k) cleared for Beckman Coulter, Inc.Clinical Chemistry510(k)2026-09-21
Biolinq Shine Autonomous Time-in-Range Microsensor (K262599): 510(k) cleared for Biolinq IncorporatedClinical Chemistry510(k)2026-09-18
iOS CamAPS FX (K261896): 510(k) cleared for CamDiabClinical Chemistry510(k)2026-09-16

Which related categories and locations should I check?

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510(k) clearances (414) Class II device recalls (320) Class I device recalls (19) Class III device recalls (11)

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Radiology (56) Orthopedic (53) Cardiovascular (52) General & Plastic Surgery (44) Dental (32) Gastroenterology & Urology (27) Neurology (23) Microbiology (21) General Hospital (14) Anesthesiology (12) Obstetrics & Gynecology (9) Ophthalmic (7)

Browse by record type by specialty

Radiology devices: recent FDA 510(k) clearances (56) Orthopedic devices: recent FDA 510(k) clearances (53) Cardiovascular devices: recent FDA 510(k) clearances (52) General & Plastic Surgery devices: recent FDA 510(k) clearances (44) Dental devices: recent FDA 510(k) clearances (32) Gastroenterology & Urology devices: recent FDA 510(k) clearances (27) Neurology devices: recent FDA 510(k) clearances (23) Microbiology devices: recent FDA 510(k) clearances (21) Clinical Chemistry devices: recent FDA 510(k) clearances (15) General Hospital devices: recent FDA 510(k) clearances (14) Anesthesiology devices: recent FDA 510(k) clearances (12) Obstetrics & Gynecology devices: recent FDA 510(k) clearances (9) Ophthalmic devices: recent FDA 510(k) clearances (7)

Frequently asked questions

How many FDA 510(k) clearances and recalls: Clinical Chemistry devices are listed?

15 records from U.S. FDA openFDA, last refreshed automatically. The most recent is dated 2026-10-23.

Can I get alerts for Clinical Chemistry?

Yes. FDAPulse can email you new records matching this filter; plans are listed on the FDAPulse page.

Source: U.S. FDA openFDA. Informational only. RSS feed of new records

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